First Opinion is STAT’s platform for attention-grabbing, illuminating, and provocative articles concerning the life sciences writ giant, written by biotech insiders, well being care employees, researchers, and others.
To encourage strong, good-faith dialogue about points raised in First Opinion essays, STAT publishes chosen Letters to the Editor obtained in response to them. You’ll be able to submit a Letter to the Editor right here, or discover the submission kind on the finish of any First Opinion essay.
The story
“Shared decision-making on vaccines isn’t the enemy,” by Peter M. Sandman
The response
Peter Sandman’s current STAT First Opinion is deeply deceptive in its framing of “shared medical decision-making,” or SCDM, as synonymous with knowledgeable consent. Its false implication is that critics of coverage modifications someway misunderstand affected person autonomy.
SCDM is neither a medical-legal synonym for knowledgeable consent nor a safeguard for vaccine entry. Suggesting in any other case is gaslighting: It suggests prior medical observe lacked knowledgeable consent, which is unfaithful, whereas obscuring the true penalties: diminished vaccine uptake.
It’s helpful to tell apart amongst 4 completely different ideas.
First, in medical observe, “knowledgeable consent” is a well-defined moral and authorized obligation: A clinician should disclose the fabric dangers, advantages, and alternate options of a really useful intervention and procure the affected person’s voluntary settlement to proceed. The doctrine emerged from early Twentieth-century tort legislation grounded in bodily autonomy and it protects affected person company in each medical encounter — vaccination included — no matter whether or not a advice carries an SCDM label.
Second are routine vaccine “suggestions”: evidence-based determinations that an individual ought to obtain a vaccine as a result of specialists have concluded the advantages clearly outweigh the dangers, speaking that vaccination is the medically most popular plan of action. Knowledgeable consent nonetheless applies — dangers and advantages are mentioned, questions answered, and sufferers might decline.
Third, suggestions are usually not “mandates.” Suggestions don’t compel vaccination. States might independently require sure vaccines for varsity attendance or well being care employment to guard inhabitants well being. It is a distinct coverage selection that balances particular person liberty with collective threat. In 1905, because the idea of knowledgeable consent was taking form, the Supreme Court docket upheld vaccine mandates in Jacobson v. Massachusetts, recognizing an appropriate coexistence.
Lastly, SCDM is an unclear, amorphous and continuously misconstrued coverage label. SCDM isn’t a authorized customary for affected person consent and it isn’t a transparent advice.
I criticized SCDM lengthy earlier than it was misappropriated by anti-vaccine activists as a result of it fails to convey clear and actionable steerage to suppliers and sufferers. The present administration has worsened this drawback by taking proof out of the equation and offering even much less steerage to well being care suppliers. Robert F. Kennedy Jr., his advisers, and compatriots within the anti-vaccine motion are usually not severe about defending affected person autonomy or entry to care. They don’t share an goal to reliably facilitate significant patient-provider conversations about vaccines or to protect vaccine entry. Moderately, their purpose is to boost public doubt and to information People to harmful and unsupported conclusions about vaccines.
— Richard Hughes IV, Epstein Becker Inexperienced/George Washington College Regulation College
The response
Peter Sandman is true about one vital factor: Vaccine conversations can and must be higher. I additionally agree that shared decision-making (SCDM) isn’t inherently improper as a framework for discussing vaccines, neither is affected person company one thing clinicians ought to concern.
The place I diverge is within the assumption that presumptive suggestions undermine company or moral knowledgeable consent. In day by day pediatric observe, shared decision-making is already occurring, typically greater than is acknowledged. A presumptive advice doesn’t take away selection. It establishes a place to begin grounded in proof {and professional} duty, then opens area for dialogue.
What erodes belief isn’t presumption, however the failure to pay attention, to acknowledge concern and identification, and to acknowledge that vaccine hesitancy isn’t about knowledge alone. Too typically, the true breakdown happens when the dialog turns into narrowly centered on “getting the vaccine given” somewhat than on constructing understanding and belief.
In observe, we routinely share the vaccine data assertion, evaluation advantages and dangers, and reply questions. That course of is knowledgeable consent. That course of is shared decision-making. Households are usually not passive recipients of care in these encounters, even when clinicians start with a robust advice.
Prevention provides a novel problem. When youngsters are wholesome, the absence of hurt is well misinterpreted as absence of threat. The menace is summary, the profit invisible. These are emotionally charged conversations, formed by identification, previous experiences, and broader system frictions, not just by proof high quality.
A lot of the resistance to SCDM amongst clinicians stems from uncertainty about documentation, variability in who can have interaction in it throughout states, and concern of added administrative burden, not from disregard for affected person company. Labeling sure vaccines as SCDM dangers reinforcing the false sign that proof is weaker, even when medical conversations haven’t meaningfully modified. If a clinician makes a presumptive advice, shares the VIS, listens fastidiously, and addresses considerations actually, shared decision-making has already occurred.
The answer isn’t abandoning presumption, however restoring empathy, curiosity, and belief because the central objectives of vaccine conversations.
— Diego Hijano, St. Jude Youngsters’s Analysis Hospital
The story
“Did my prostate most cancers screening do extra hurt than good?” by Howard Wolinsky
The response
As a lately retired household doctor, I appreciated your article. I might identical to to make two factors relating to knowledgeable consent and legal responsibility. All through my total profession courting again to the Eighties, I by no means ordered a screening PSA with out discussing the professionals and cons. Particularly, whereas it’d result in wanted early remedy, it may also result in pointless additional testing, biopsies, and remedy. Additionally, their first PSA may be essentially the most tough to interpret as they don’t have any baseline PSA for comparability. Lastly, the legal responsibility threat could also be better within the U.S., making extra conservative approaches to this drawback tougher. No person with metastatic prostate most cancers goes to understand their doctor’s previous makes an attempt to attenuate intervention.
— Thomas Peterson
The story
“What I bought improper 33 years in the past as a brand new pediatrician speaking to oldsters about vaccines,” by Richard Besser
The response
Dr. Besser nailed it, in my view. When mother and father interview a pediatrician within the prenatal interval and points about one’s observe are delineated, immunization schedules will doubtless be a degree of debate. Dr. Besser encourages listening to the mother and father’ perspective about vaccines and importantly the place they acquire this data (e.g., the web, present insurance policies from HHS). Listening to that, the pediatrician can then present details about the observe’s evidence-based method to immunizing infants, youngsters, and adolescents. If the mother and father are usually not in sync with these pointers, the pediatrician can acknowledge this disparity and conform to work with the them over time to win their belief and in the end totally immunize their youngster. If the mother and father resolve to decide on this observe to care for his or her child, they acknowledge the observe’s pointers relating to immunizations so that they probably may very well be amenable to altering their views.
If that doesn’t occur, it’s attainable this isn’t the perfect observe for this household relating to the well-being of the kid and parting methods could be the only option.
— Larrie Greenberg, George Washington College College of Drugs and Well being Sciences/Youngsters’s Nationwide Hospital
The story
“The 30-year itch: Hormone promotion is again with a vengeance,” by Patricia Bencivenga and Adriane Fugh-Berman
The response
Whereas I agree with the general sentiment on this op-ed, I’m greater than a bit of pissed off that the authors didn’t embody very, essential caveats relating to the Girls’s Well being Initiative (WHI) trial they appear to be referencing all through. A few of the largest caveats in my view embody:
The research evaluated just one type of estrogen (oral conjugated equine estrogen) and one progestin (medroxyprogesterone acetate). These kinds are fairly outdated by right this moment’s requirements.
Hormones got orally. (This isn’t true throughout the board anymore.)
The typical participant was 63 years outdated, which is about 10+ years previous menopause. The authors additionally state “one third of the individuals had been of their 50s.” That’s nonetheless a lot older than most girls after they begin hormone remedy.
To extrapolate on unwanted effects discovered within the WHI with out giving vital context weakens the argument for this op-ed, which is a disgrace, as a result of I additionally consider that the advantages and the unwanted effects are being manipulated by these wishing to make cash on this area. To make a very certified argument, we should make certain that we’re not doing the identical factor as these we’re arguing in opposition to.
— Jessica DiGiacinto, MedShadow Basis
The story
“The difficult fact about urinary tract infections within the aged,” by Neil Gaffin
The response
You’re damned in the event you do and damned in the event you don’t. These infectious illness docs have been shouting this mantra for 40 years and but there isn’t a new answer. No physician needs to contribute to antibiotic resistance. But when a type of aforementioned sufferers will get septic and dies (and a few invariably do), and they didn’t get antibiotics for the attainable UTI, the docs are utterly liable and didn’t comply with primarily the usual of care. This performs out day by day at each hospital. And the demented affected person is sort of by definition asymptomatic. It’s irritating for everybody.
— David Wiebe
The story
“U.S. scientists should compete internationally, identical to auto and metal employees do,” by Mikko Packalen
The response
Whereas this essay is an attention-grabbing thought train, implementation would trigger each short- and long-term injury to U.S. science. It’s harmful to advocate in favor of world competitors for NIH grants when inside U.S. competitors is already so fierce.
The Nationwide Most cancers Institute (NCI) payline in 2025 for RO1 grants, the key funding mechanism for long-term particular person tasks, was 4%. In broad phrases, because of this solely 4 out of each 100 purposes submitted had been funded. This isn’t the one NIH institute which funds such a low proportion of the general grants submitted.
Many younger scientists are already transferring into positions outdoors of academia, citing the inherent difficulties of life as an educational researcher, which incorporates the unbelievable issue in successful funding. Inviting worldwide competitors would improve the variety of purposes, additional drive down success charges, and in flip disincentivize U.S. skilled scientists from staying in analysis.
I agree that the U.S. doesn’t have the perfect of each sort of analysis, and that the U.S. doesn’t have to have the perfect of each type of analysis. Supporting this, NIH has historically (though current coverage strikes are altering this) offered funding to worldwide researchers as a part of subawards to U.S. researchers. These direct collaborations spur U.S. science whereas additionally permitting analysis that’s finest finished outdoors of the U.S. resulting from exterior experience to occur outdoors of the U.S. Metal and auto firms are promoting a product and are competing for patrons. Disruption and ache resultant from competitors may result in progress with a view to climate the competitors.
Nonetheless, what I believe we see extra continuously within the present financial markets is slicing corners to undercut rivals and promote a less expensive, typically worse, product. Worldwide science isn’t inherently higher or worse than U.S. science, however inviting competitors now, at a time the place U.S. tutorial researchers counting on NIH funding are already stretched so skinny, can be catastrophic.
— Brad Davidson
The story
“I’m a CVS pharmacist. My retail pharmacy colleagues and I face a disaster,” by Chris Eggeman
The response
I’m one of many thousands and thousands of pissed off CVS clients. Sadly our anger will get directed to the pharmacist and technicians. What can we people do? How can we assist? Ought to we take our enterprise elsewhere? Please give us some concepts how we may be a part of the answer.
— Bruce McGarvey
